An Exploratory Study on Efficacy and Safety of Fosaprepitant and Palonosetron Hydrochloride for Injection in Preventing CINV From Multi-Agent HEC

NCT07482891 | Recruiting Phase 4

• 1 other identifier: 2026-012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicenter, non-comparative, open-label trial design aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by hyperemetic chemotherapy (HEC) over multiple days. Eligible subjects were screened and assigned to Arm 1 or Arm 2 according to medical protocol. Arm 1: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine; Arm 2: Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone. Study drug administration commenced within 48 hours post-randomization, with follow-up visits and examinations completed as per protocol.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving Complete Control of CINV from the first administration until 24 hours after the last administration of chemotherapy

  To compare the proportion of subjects achieving and maintaining a complete response (defined as no emetic episode and no need for rescue medication) from the first administration until 24 hours after the last administration of chemotherapy

  from the first administration until 24 hours after the last administration of chemotherapy

Secondary Outcomes (8)

• Percentage of patients achieving Complete Control of CINV during the acute phase, delayed phase, and super-delayed phase

  acute phase: from first chemotherapy administration until last administration; delayed phase: until 120 hours after last administration; super-delayed phase: from 120 hours to 168 hours after last administration

• No significant nausea

  from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration

• No nausea

  from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration

• No emetic

  from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration

• No rescue medication

  from first chemotherapy administration until last administration, until 24 hours after last administration, until 120 hours after last administration, and from 120 hours to 168 hours after last administration

Study Arms (2)

Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine

EXPERIMENTAL

Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection; Drug: Dexamethasone; Drug: Olanzapine

Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone

EXPERIMENTAL

Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection; Drug: Dexamethasone

Interventions

Fosrolapitant and Palonosetron Hydrochloride for Injection DRUG

On the first day of chemotherapy, a 60-minute intravenous infusion is administered prior to treatment

Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone; Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine

Dexamethasone DRUG

On the first day of chemotherapy, take 12mg orally. From the second day of chemotherapy until 3 days after chemotherapy concludes, take 3.75mg orally twice daily

Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone; Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine

Olanzapine DRUG

From the first day of chemotherapy until three days after its completion, take 5mg orally each night before bedtime

Fosrolapitant and Palonosetron Hydrochloride for Injection + Dexamethasone + Olanzapine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years, any gender, voluntarily signed informed consent form (ICF), with good compliance;
• Histologically or cytologically confirmed malignant solid tumour;
• No prior exposure to any chemotherapeutic agents;
• First-time participants with malignant solid tumours scheduled to receive a treatment regimen based on multi-day HEC chemotherapy (HEC refers to the risk of anti-tumour drug-induced nausea and vomiting as defined in the 2023 Edition of the Chinese Guidelines for the Prevention and Treatment of Nausea and Vomiting Associated with Anti-tumour Therapy; 'multi-day' denotes each chemotherapy cycle lasting at least 3 days);
• No impairment in speech, hearing, or comprehension;
• Expected survival ≥ 3 months;
• ECOG : 0-1;
• Organ function must be adequate and meet the following criteria:
• Neutrophil count ≥ 1.5 × 10⁹/L;
• Haemoglobin ≥ 90 g/L;
• Platelet count ≥ 100 × 10⁹/L;
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
• In patients without known liver metastases, aspartate aminotransferase ≤ 2.5 × ULN and/or alanine aminotransferase ≤ 2.5 × ULN (for patients with liver metastases, may be relaxed to ≤ 5 × ULN);
• Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 ml/min;
• Electrocardiogram: QTc ≤ 450 ms (males), QTc ≤ 470 ms (females);

You may not qualify if:

• Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastases or intracranial hypertension;
• Subjects who have received radiotherapy within 7 days prior to enrolment, extensive radiotherapy (e.g., whole-chest or whole-abdomen radiotherapy) within 3 months prior to enrolment, local palliative radiotherapy (e.g., for bone or lymph node metastases) within 1 month prior to enrolment, or who are scheduled to undergo any radiotherapy during the study period;
• Administration within 2 days prior to enrolment of medications with potential antiemetic effects: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, or secloperazine;
• Initiation of benzodiazepine or opioid therapy within 2 days prior to enrolment (excluding zolpidem, temazepam, or midazolam administered alone daily);
• Subjects who commenced morphine use within 7 days prior to enrolment (excluding those on stable doses);
• Systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone, or prednisolone) or sedating antihistamines (e.g., diphenhydramine) administered within 7 days prior to enrolment (Note: Single-dose steroids for contrast allergy prophylaxis, or topical/inhaled administration are permitted);
• Use of palonosetron within 14 days prior to enrolment;
• Use of NK-1 receptor antagonists within 28 days prior to enrolment;
• Vomiting and/or retching, nausea occurring within 24 hours prior to enrolment;
• Severe cardiovascular disease within 3 months prior to enrolment, including but not limited to acute myocardial infarction, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association \[NYHA\] Class II to IV), or history of severe cardiac conduction abnormalities (e.g., torsades de pointes ventricular tachycardia);
• Concurrent active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), active hepatitis C (HCV-Ab positive with HCV-RNA ≥ ULN), known acquired immunodeficiency syndrome (AIDS) or HIV-positive status, or syphilis-positive status;
• Concurrent conditions precluding dexamethasone administration, such as active infections (e.g., pneumonia) or uncontrolled conditions (e.g., diabetic ketoacidosis, intestinal obstruction);
• Known contraindications and/or allergies to study medications;
• Participation in another clinical trial within 30 days prior to enrolment (as determined by the use of study medication);
• Subjects deemed by the investigator to have other conditions rendering them unsuitable for this study.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

MeSH Terms

Conditions

Vomiting

Interventions

Palonosetron; Injections; Dexamethasone; Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzodiazepines; Benzazepines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 19, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)